This study evaluated the microscopic safety of ultrasound neuromodulation delivered using the BrainSonix BX Pulsar 1002 by performing histological analysis of human brain tissue following exposure. Rather than relying solely on clinical outcomes or imaging, the authors examined tissue at the cellular level to detect subtle structural, vascular, or inflammatory changes.
Under the tested conditions, no evidence of ultrasound-induced tissue injury was observed, including no hemorrhage, necrosis, or inflammatory response. This work provided a critical layer of biological validation, strengthening confidence in the tissue-level safety of low-intensity focused ultrasound. These results were consistent even at intensities as high as ISPTA.3= 14 W/cm2. The findings supported the use of the BX Pulsar 1002 in protocols involving repeated exposures and deep-brain targets, complementing other safety evidence across the neuromodulation literature.
